IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

ConditionRelapsed/Refractory Multiple Myeloma (RRMM)

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 75 years old, male or female;

Diagnosed with relapsed/refractory multiple myeloma (RRMM) according to IMWG criteria, and have received at least 2 lines of treatment including one proteasome inhibitor and one immunomodulator; with documented disease progression (based on examination data) during or within 12 months after the latest anti-myeloma treatment (subjects whose last-line treatment was CAR-T therapy are not required to have progression within 12 months);

Serum monoclonal protein (M-protein) level: ≥5 g/L f；

Urine M protein level ≥200 mg/24 hours;

Disqualifiers

Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;

Multiple myeloma patients with plasma cell leukemia;

Patients with amyloidosis;

Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

Trial design

Design model

Single group

Treatments tested in this trial

IASO206 injection
Drug
The third-generation self-inactivating lentiviral vector that carries a BCMA-targeted CAR.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: IASO206Active comparator 1 intervention

Trial outcomes

Primary outcomes

The incidence and severity of adverse events（AEs）

Cytokine release syndrome (CRS) and ICANS would be graded according to the ASTCT consensus. All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Time frame